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NCT Number: NCT07234630

Role of Fibrinolytic Activity in Neoplastic Pathologies Complicated by Coagulopathy

The aim of this research is to measure fibrinolytic activity in neoplastic pathologies in order to provide preliminary data on which to base a future, larger-scale study to determine predictive markers of complication in order to improve patient management.

Primary purpose: measure plasminogen concentration on day 1 in subjects diagnosed with malignant hematological disease, solid tumors, or septic shock, with coagulopathy.

Secondary purpose:

* Estimate the difference in plasminogen concentration at D1 in patients with coagulopathy between subjects with a diagnosis of haematological malignancy and those with solid tumor * Estimate the difference in plasminogen concentration at D1 in patients with coagulopathy between subjects with a diagnosis of haematological malignancy and those with septic shock * Estimate the difference in plasminogen concentration on Day 1 in patients with coagulopathy between subjects with a diagnosis of solid tumor and those with septic shock.

In the 3 groups, subjects with a diagnosis of haematological malignancy, solid tumor, septic shock, presenting with coagulopathy:

* Evaluate the correlation between the concentration of circulating plasminogen active on Day 1 and the occurrence of a bleeding complication within 28 days of admission to critical care. * Evaluate the correlation between the concentration of circulating plasminogen active on Day 1 and the occurrence of a thrombotic complication, within 28 days of admission to critical care. * Evaluate the predictive performance of circulating active plasminogen concentration on Day 1 in the need for extra renal purification within 28 days of admission to critical care. * Estimate the differences at each time point (D1, D3, D7) in haemostasis markers and markers of fibrinolytic activity and its regulation.

Assess the link between fibrinolytic activity and :

* The diagnosis of disseminated intravascular coagulation (DIC), * The risk of haemorrhage * Risk of organ failures * Thrombotic risk * Risk of organ failure * Neutrophile activation and circulating NETs levels

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Key information

Conditions

Hematologic Neoplasms Blood Coagulation Disorders Disseminated Intravascular Coagulation Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Neoplasms Neoplasms by Site Solid Tumor Metastatic Cancer Advanced Cancer Thrombophilia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

For all groups:

  • Age > 18 years
  • Patient hospitalized in Emergency Medicine, Intensive Care Medicine or Hematology/Oncology Intensive Care, Hematology/Oncology Service or Hepatobiliary and Digestive Surgery Service
  • Coagulopathy defined by the combination of thrombocytopenia (< 100 G/L) and increased INR (>1.2)

Group 1: Malignant hemopathies with large tumor masses:

  • Acute myeloblastic or lymphoblastic leukemia with leukocyte count (or blasts) >50G/L in peripheral blood, or
  • Lymphoma documented by tissue biopsy, with biological tumor lysis syndrome, diagnosed according to Cairo and Bishop criteria (3).

Group 2: Locally advanced or metastatic solid tumors with DIC:

  • Prostatic adenocarcinoma
  • Malignant pancreatic or biliary tract tumor (cholangiocarcinoma),
  • Scheduled complex hepatobiliary carcinological surgery,
  • Metastatic adenocarcinoma of the digestive tract.

Group 3: Control group (free of neoplastic pathology, with well-studied coagulopathy): Septic shock

Exclusion criteria

  • Patient under protective supervision (guardianship or curatorship)
  • Pregnant women
  • Patients weighing less than 50 kg
  • Patient already included in the study
  • Congenital hemostasis disorders
  • Active bleeding at the time of inclusion
  • Patient with cirrhosis
  • Patients receiving curative anticoagulation therapy
  • Patients with a spontaneous INR > 1.2 in a previous blood test in a context of fibrinolytic insufficiency
  • Each group is exclusive of the other, for example :

For Group 1 (Neoplastic pathologies): Presence of documented sepsis at the time of inclusion

Treatment and study plan

An additional volume of blood will be drawn as part of routine follow-up care

Biological

The biological samples collected correspond to blood samples taken from venous or arterial catheters inserted at the time of admission as part of routine care. The total volume of blood collected at D1 and D7 was 18.5 mL (3 x 4 mL citrate tubes, 1 x 4 mL EDTA tube and 1 x 2.5 mL Paxgene tube). The volume of blood drawn at D3 was 16 mL (3 x 4 mL citrated tubes, one 4 mL EDTA tube).

Samples are immediately analyzed in the hematology/hemostasis laboratory for NETs and hemostasis, with the remaining portion of the tube centrifuged before plasma is frozen at -80°C for plasma analysis. The Paxgene tube can be used for non-identifying genetic analyses.

Primary outcomes

  1. Plasminogen measurement at D1 in hematologic malignancy, solid tumor and septic shock groups.

    Time frame: Day 1

    The biological samples collected correspond to blood samples taken from venous or arterial catheters inserted at the time of admission as part of routine care.

Secondary outcomes

  1. Measurement of various haemostasis markers

    Time frame: Day 1, 3 and 7

    Measurement of platelet count, PT/INR, aPTT, fibrinogen, factor V, D-dimers, antithrombin III, factor VIII

  2. Measurement of markers of fibrinolytic activity and its regulation

    Time frame: Day 1, 3 and 7

    Assay of t-PA, u-PA, PAI-1, u-PAR, plasmin activity

  3. Analysis of parameters closely associated with serum NET assays

    Time frame: Day 1, 3 and 7

    Measurement of neutrophil fluorescence, circulating nucleosomes

Study contacts

Contact information is provided by the study sponsor or research team.

Raphaël Clere-Jehl

CONTACT

[email protected]

+33 3 88 12 82 23

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Acronym: NEO-COAG

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Nov 18, 2025
Registry last updated
Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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